Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT) (HIT)
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ClinicalTrials.gov Identifier: NCT00790894 |
Recruitment Status :
Terminated
(The low accrual rate of the study (25% of the expected accrual rate))
First Posted : November 14, 2008
Last Update Posted : May 18, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: ixabepilone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Randomized Trial of Ixabepilone Administered Weekly or Every Three Weeks in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Chemotherapy in the Neo-adjuvant or Adjuvant Setting |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: ixabepilone
Arm A: ixabepilone will be given at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 21 days cycle. |
Experimental: 2 |
Drug: ixabepilone
Arm B: ixabepilone will be given at a dose of 20 mg/m2 as a 3-hour intravenous infusion on Days 1, 8 and 15, then 1 week off in a 28-days cycle. |
- The primary endpoint of the study is the best Overall Response (OR). [ Time Frame: At 6, 12 and 24 weeks ]
- Efficacy endpoints: time to response, PFS, TTF, duration of response [ Time Frame: Duration of the study ]
- OS Toxicity endpoints: incidence of hematological and non-hematological toxicities [ Time Frame: Duration of the study ]
- Translational endpoints [ Time Frame: Duration of the study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent
- Female patients aged 18 to 75 years inclusive
- Prior chemotherapy in the adjuvant or neo-adjuvant setting
- Diagnosis of HER-2 negative (HER-2 <2+ by immunohistochemistry and/or FISH negative) metastatic breast adenocarcinoma confirmed by the pathology department of the enrolling institution
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Measurable disease by the Response Criteria in Solid Tumors (RECIST) method
- Laboratory values within the specified ranges within 1 week of study enrolment:
- Absolute neutrophil count of ≥ 1.5 x 109/L
- Thrombocyte count of ≥ 100 x 109/L
- Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease
- Prior hormonal therapy for locally recurrent or metastatic disease allowed
- AST and ALT ≤ 2.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- Recovery from prior palliative radiotherapy for bone metastases
Exclusion Criteria:
- Because of concerns that ixabepilone metabolism may be inhibited by potent cytochrome P450 3A4 inhibitors, patients must not receive the following medications, up to 72 hours prior to initiation of study therapy and until they come off treatment with ixabepilone: amprenavir, delavirdine, voriconazole, erythromycin, cyclosporine, troleandomycin, terfenadine, ketoconazole, nelfinavir, and ritonavir
- Patients with CTC grade 2 or greater neuropathy at baseline
- Patients with any history or evidence of brain an/or leptomenigneal metastasis
- Patients with clinically significant cardiac disease (e.g. unstable angina, congestive heart failure, myocardial infarction) within 6 months from study entry
- Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol
- Any concurrent active malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix (subjects with a history of previous malignancies but without evidence of disease for 5 years will be allowed to enter the trial)
- Prior severe HSR to agents containing Cremophor EL
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks from the last dose of ixabepilone, in such a manner that the risk of pregnancy is minimized WOCBP include: any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; women on hormone replacement therapy with documented FSH level > 35mIU/mL. Even women who are practising abstinence or whom their partner is sterile (e.g. vasectomy) should be considered of childbearing potential.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrolment or prior to study therapy
- No other concomitant chemotherapy, endocrine therapy, immunotherapy, radiation therapy (except for palliative radiotherapy for bone metastases) or investigational treatments are allowed during subject's participation in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790894
Greece | |
Hippokration General Hospital, Oncology Department | |
Athens, Greece, 11527 | |
University Hospital Attikon, Second Department of Internal Medicine, Oncology Section | |
Athens, Greece, 12462 | |
Agii Anargiri Cancer Hospital, Third Department of Medical Oncology | |
Athens, Greece, 13122 | |
Hygeia Hospital, First Deparment of Medical Oncology | |
Athens, Greece, 15123 | |
Hygeia Hospital, Second Department of Medical Oncology | |
Athens, Greece, 15123 | |
Alexandra Hospital, Department of Clinical Therapeutics | |
Athens, Greece | |
University General Hospital of Ioannina, Medical Oncology Department | |
Ioannina, Greece, 45500 | |
University Hospital of Larisa, Department of Medical Oncology | |
Larisa, Greece, 41110 | |
University Hospital of Patras, Department of Medicine, Division of Oncology | |
Patras, Greece, 265 00 | |
Metropolitan Hospital, First Department of Medical Oncology | |
Piraeus, Greece, 18547 | |
Metropolitan Hospital, Second Dept of Medical Oncology | |
Piraeus, Greece, 18547 | |
"Theageneio" Cancer Hospital, Third Department of Medical Oncology | |
Thessaloniki, Greece, 54007 | |
"Papageorgiou" General Hospital, Department of Medical Oncology | |
Thessaloniki, Greece, 56429 |
Principal Investigator: | George Fountzilas | Papageorgiou General Hospital |
Responsible Party: | G. Fountzilas/President, Hellenic Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00790894 |
Other Study ID Numbers: |
HE 11A08 |
First Posted: | November 14, 2008 Key Record Dates |
Last Update Posted: | May 18, 2011 |
Last Verified: | May 2011 |
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